During last month’s NYSCC Suppliers' Day, several attendees expressed frustration regarding the continuous delay of the US Food and Drug Administration’s (FDA’s) Final Sunscreen Monograph. Cosmetics & Toiletries asked its LinkedIn members to comment regarding this delay. Here’s what the market had to say.

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Question: What is your reaction to the delay of the US FDA's Sunscreen Monograph? How is it affecting your work and how it is affecting sun protection in the United States?

Answer 1: The classification of sunscreens as over-the-counter (OTC) drugs may be the basic problem. However, in my opinion, the delay leaves room to resolve difficulties. In this case, an imperfect decision may be better than no decision since there is always the opportunity to revise and amend the text. It may be that the delay is due to the Safe Cosmetics Act in discussion, but on the other side, this gives strength to groups asking for stricter regulations on cosmetics. Is there any known (reasonable) reason why the FDA is delaying?

Answer 2: My reaction? As a fair-skinned father and husband, I have been purchasing European formulations of a product marketed by a certain L'Oréal subsidiary for our family for several years. There is now on the USA market a "half-full" version of this product; if you follow sunscreen chemistry, you will see what I mean by this. Of course, it's not just what we do, in survival mode, for ourselves and our families, but what we should do as cosmetics professionals for our fellow human beings, and what we should do as chemists in the employ of personal care enterprises. I'll tell you this: At every opportunity, I let people know that sunlight (beyond the minutes of daily exposure needed for sterol synthesis) damages skin; that suntans should be relegated to their former image of forced labor in the fields; and that governments that drag their feet while a melanoma epidemic is in progress should be replaced at the ballot box.

Answer 3: I can't comment too much as I'm not a US formulator, but this has been dragging on in one form or another for most of the time that I have been involved in the industry. I suspect that as mentioned above, products being classified as OTC drugs is partly the issue. From what I understand, the FDA has been criticized in relation to approvals of pharmaceuticals such as anti-depressants, some of which have been found to have unfortunate side effects. I suspect in this sort of climate, the administration feels that it needs to be seen taking its time, to ensure it is thorough. I come from the European mentality; to me, it would make much more sense to pull sunscreens out of OTC classification. I don't think, however, that will happen any time soon. US market formulators and manufacturers have my sympathies, as I know it is incredibly frustrating.

Answer 4: Well, could it be the lack of or fewer rules in United States regarding cosmetics that may be the reason for the OTC classification? If so, why not take the chance and put them in the Safe Cosmetics Act? (Admittedly, I am not well-versed in this text.) The problem is more than a minor issue; if you see the latest announcement from the Environmental Working Group (EWG) regarding sunscreens, in some cases, the group says that products are so bad that cannot be sold in European Union (EU).

Answer 5: Firstly, I take the FDA’s delay with a grain of salt. The first time I heard about the proposed review of the Monograph, it was in my third year in school, back in 1985! Since then, it has been proposed, revised, etc. What I am most worried about in the Monograph is some of the proposed labeling changes that would bring the United States closer in line with the European standard. While I feel that nanometer wavelengths and other labeling information is more useful, I also believe that there will be a scramble to catch up in the knowledge, as well as to redesign all the packaging. Otherwise, I think a more coherent direction in this matter, and in cosmetics in general, from the FDA is a good thing.

Answer 6: I have never understood the rationale behind the OTC classification for sunscreens. In my opinion, I believe it would be more sensible that, rather than being incorporated into "THE" Safe Cosmetics Act, sunscreens be incorporated into "A" Safe Cosmetics Act. Incorporation into the current proposed Safe Cosmetics Act would be disastrous for the US industry. Whilst the current system could use some improvement, it should be possible to do so without destroying the majority of the industry. (Sorry, off on a tangent, there.)

Answer 7: I agree with "A" Safe Cosmetic Act; if the US industry would move in this direction I am sure it could find a good solution. Maybe the OTC classification is partly due to the lack of a regulation, and so sunscreens have been placed in the nearest classification available; however, the FDA does not seem to have too many excuse for the delay.

Answer 8: This all reminds me of the early 1980s when I worked at Givaudan in Clifton, New Jersey. We had a "revolutionary" UVA sun filter called, appropriately enough, Parsol 1789 (INCI: Avobenzone). At that time, I believe it was the only product absorbing in the UVA spectrum but we could not sell it, as it was not approved by the FDA...or, we could sell it but clients could not make any claims! I think that Lauder used it in a new line called Lauder SUN, but they had to pull it off the market since Parsol 1789 was not on the FDA Monograph. When it was finally approved many years later, the patent had expired and Givaudan no longer sold because Hoffmann-La Roche had taken over the marketing of the company’s sunscreens. The bottom line is: the consumer could not benefit from the ingredient’s UVA protective abilities because the FDA was so slow to move. I am not a chemist, so maybe products like titanium dioxide did provide broad-spectrum protection, but it was all very frustrating. Now I think DSM has purchased the sunscreen business. Who can keep up with all these changes!?

Answer 9: The monograph delay is indeed reminiscent of the 1980s with avobenzone (Parsol 1789)—very much so. In a previous post, I obliquely mentioned two other sunscreen actives that were developed by L'Oréal that, to this day, are not included in the relevant FDA monograph. The L'Oréal actives—i.e., terephthalylidenedicamphor sulfonic acid (Mexoryl SX) and drometrizole trisiloxane (Mexoryl XL in combination with the SX active) represent an advance beyond avobenzone, just as avobenzone was an advance beyond methyl anthranilate and sun blockers like titanium dioxide. L'Oréal, like its counterpart Givaudan with its avobenzone, was watching its patents twist in the wind even while American consumers were being denied the benefit of better UVA protection. In the end, L'Oréal partially overcame the monograph obstacle by filing a new drug application (NDA) for La Roche-Posay Anthelios, but unfortunately, the version of Anthelios now available in the United States only contains the water soluble Mexoryl SX. The non-USA version of the product has the full Mexoryl XL, which includes the synergistic, oil-soluble UVA blocking silicone drometrizole trisiloxane. I've been using the "full" version of Anthelios for a few years, but until the FDA monograph includes L'Oréal's innovative compounds, few Americans will have the better sun protection enjoyed in much of the rest of the world.